What led to the outbreak?

With the advantage of hindsight, it is easy to see the mix of variables that created the conditions enabling listeriosis to take hold. Among the many variables, is simply the fact that the disease involves a virulent bug that is very difficult to pinpoint and even harder to keep in check. Beyond that, a number of coincidences as well as specific decisions, which were not thoroughly thought through or executed, may have contributed to the 2008 outbreak. Whatever the explanation, the reality is Listeria defeated the best efforts of all those trying to prevent it from entering the food supply, including workers attempting to control it in the Maple Leaf Bartor Road plant. It also evaded the oversight systems of both Maple Leaf Foods and the federal government (CFIA). As a result, a segment of the population that is the most vulnerable was exposed to its damaging and sometimes deadly effects.

Then, there is the fact that the food business has undergone a transformation in recent years, due in great part to new technologies and globalization. The way food is raised, processed, transported and distributed to consumers now means that food produced in one part of the country is available within days in communities big and small all across the country.

This ready access to a wide variety of foods, especially ready-to-eat products that are a growing staple in many Canadians' busy lives, is a bonus for both consumers and industry. However, each step in the modern food chain increases the chance of food contamination. It also makes tracing the source of a foodborne illness when an outbreak occurs far more difficult than in the past.

These conditions were affected by a series of modifications to federal food safety policies and programs that had been introduced by the CFIA in the lead-up to the event. These recent changes contributed to additional complication and confusion when it was finally obvious that a major listeriosis outbreak was underway. Many of the new initiatives were not well understood or only partially implemented, at the very time that clear communications, cooperation and coordinated action were required on the part of multiple players.

In addition, the fact that food safety and public health is shared among three levels of government, using different systems and procedures and operating on different timetables made things even more complicated. These challenges were intensified by the time of year that the events took place -  the summer vacation period. Senior management in several key organizations were on vacation, which may have contributed to delays in decision making in some situations.

In the end, the lost time made little difference because most of the contaminated food was on the market and eaten before people in the food safety and public health sectors were even aware of the outbreak's existence.

We identified weaknesses in four critical parts of the food safety system that, collectively, led to the Listeria outbreak.

1. Maple Leaf Foods believed its procedure to control listeria was working - it was not

Like all firms operating food processing plants regulated by the federal government, Maple Leaf Foods was required to maintain a hygienic operating environment in order to control bacteria.

At the outset of the 2008 listeriosis outbreak, Maple Leaf Foods was viewed as a good company using the latest food safety control systems. It viewed itself then, and continues to view itself now, as a leader in the industry. The Bartor Road plant was considered by many to be a compliant plant in that it routinely met all the regulatory requirements under the federal Meat Inspection Act and got satisfactory marks for complying with the government's inspection and testing tasks. When Canadian Food Inspection Agency's inspectors identified any compliance problems, the plant addressed them. Bartor Road's management maintained the necessary required records, ensured that staff training took place, and made sure its quality assurance program was completed.

Much of the credit for Maple Leaf Foods' good reputation rested with the firm's in-house safety plan. The company had introduced its own food safety procedures - which includes a comprehensive HACCP¹ plan, an additional layer of food safety protection at the end of the nineties  - years earlier than was required by the regulations.

Like most food processors, Maple Leaf Foods` food safety approach laid out a hazard monitoring and control program. As a general rule, these plans are effective. Over 400 meat processing companies across the country produce tons of food products daily without incident.

The food safety plan of Maple Leaf Foods covered all expected aspects, including safety standards in the building where the food is produced, the land surrounding it, as well as the equipment used in food preparation and packaging. The plan outlined safety procedures for people working at the facility and their movements within the plant. It also identified who is in charge of various aspects of the company's operations and the corresponding levels of responsibility and accountability.

Maple Leaf Foods was confident that its monitoring and control programs would find any problems if they arose and, for the most part, they did. The company had a good track record in preventing contamination in its products. Listeria did surface periodically. When test results from environmental testing² identified the presence of Listeria, plant employees took corrective actions such as increased sanitation.

At that time, while environmental testing for Listeria was not a requirement set out in the CFIA regulations, the company was following Health Canada's Listeria Policy which recommends environmental testing. In fact, like many of Canada's ready-to-eat meat processing plants, Bartor Road actually went beyond the Policy and requirements in that the company had an extensive environmental testing program of its own.

Doing more than was required did not guarantee the company was trouble free. As early as summer and fall of 2007, the company's environmental testing program showed positive Listeria environmentaltest results from production lines 7 and 8 in the plant, every two to three weeks, at various locations on those lines.

This pattern carried on into 2008. For example, in the first week of February, the plant's environmental test results showed an increase in the number of positiveListeria results from line 7. The problem also occurred in March and April when increased numbers of positive Listeria test results showed up on line 8, every two to three weeks. During the week of May 19th, more positive test results appeared on the plant's lines 7 and 8.

With the benefit of hindsight, we now know that this problem persisted over several months before the June 3rd onset of the first case of human illness linked to contaminated Maple Leaf Foods deli meat products. Positive results for Listeria from environmental testing were also identified during the week of June 23rd.

In each instance, the plant staff took action to destroy the bug. They employed a 'search and destroy' approach - the recognized standard procedure -  sanitizing all the surfaces where the bacteria could grow on production lines and throughout the building. Every time employees intervened, the follow-up test results were negative, at least for awhile. This led to the assumption that the problem had been solved, creating a false sense of security.

What was missing was the big picture - recognizing the repeated pattern of presence of Listeria on the same production lines several weeks after the problem was presumed to have been fixed. Although data were being collected to note such instances, they were not being analyzed by the plant or company headquarters to detect trends over time. Had such analyses been conducted, the re-emergence of Listeria on a regular basis would have become obvious much sooner.

Bartor Road staff treated these occurrences as isolated incidents. Since the positive results were never looked at together, no one identified the recurring pattern and Listeria continued to thrive in the plant. Because the original source of the bacteria was not recognized and treated, the underlying cause of the contamination was not addressed until after the outbreak.

Looking back, it becomes more apparent why these warning signs were missed.

The new federal food safety procedures, including HACCP, had only been mandatory since 2005. Bartor Road was one of the first in the country to adopt this approach in 1999, making it a flagship plant for Maple Leaf Foods.

Although these procedures are now recommended by the World Health Organization for food safety, they were and are still relatively new. Both employees' understanding, and the actual implementation of this approach, was still maturing in the spring and summer of 2008. We were told Listeria was not top of mind for many people working in Bartor Road. At the time, employees were likely more inclined to look for and eliminate more frequently found bacteria such as Salmonella and E. coli.

We were told that during this period, Maple Leaf Foods was responding to a demand for large packages of deli meats. This market included hotels, restaurants, and institutions, such as long-term care homes and hospitals. There was a demand for these products in institutions, as they must offer choices to their residents/patients, and deli meat is a popular choice. To meet this increased demand, the company was operating the plant for long hours, running double shifts.

Between midnight and the morning shift, when the production lines were closed down, sanitation was being performed.

A further factor is the time required to disassemble the meat slicers and other production line equipment for a thorough cleaning and verification. While there was daily sanitation of all surfaces coming into contact with food, a complete cleaning of the entire plant only took place on the weekends and not every piece of equipment was fully dismantled. For example, we heard that to take the meat slicing machines completely apart, thoroughly sanitize and then reassemble would have required shutting down the plant for three days. We also heard that it could take considerably less time.

Post Outbreak Review

Following the outbreak, both Maple Leaf Foods and the Canadian Food Inspection Agency completed detailed reviews to determine the cause of the Listeria contamination within the Bartor Road plant.

Maple Leaf Foods convened a panel of international food safety experts in late August 2008 to investigate the source of the Listeria bacteria. The Expert Panel identified deficiencies in the company's physical, operational, sanitation, environmental, and contact-point testing. The experts concluded that the most probable cause of the outbreak was contamination of deli meat products by commercial meat slicers used on production lines 8 and 9 in the plant. The Panel determined that the meat slicers had meat residue deep inside the slicing mechanisms, which provided a breeding ground where Listeria could grow. Several pieces of equipment, including cutters and slicers, were eventually replaced.

We were informed by the manufacturer that two of the slicers were relocated to the Saskatoon Maple Leaf Foods plant in late fall 2008. This information was confirmed by the CFIA. Before going back to production the slicers were completely disassembled, fully sanitized, rebuilt, and verified by the manufacturer for their new intended use. The slicers are currently in use to slice "casing" type products.³. Extra sanitation measures have been implemented by the operator, in addition to having enhanced environmental testing conducted on the equipment both on food contact surfaces and non-food ones.

The CFIA also conducted an In-depth Review using its food safety experts in early September 2008 that corroborated many of the findings of Expert Panel. This review shed new light on additional factors that contributed to the contamination. The In-depth Review found that the Maple Leaf Foods instructions for equipment maintenance were insufficient. It noted potential cross-contamination as employees moved from one room to another. The Review also cited structural damage and maintenance issues in rooms where ready-to-eat meats were handled. As well, it highlighted several biological, chemical, and physical risks that were not incorporated into the company's food safety plan.

While there is not conclusive evidence that it played any role, it appears that construction work that took place at the Bartor Road plant a few months earlier, in the spring of 2008, could have added to these problems. The construction may have exposed the plant to moisture and could have also allowed Listeria to enter the facility, making sanitation control more difficult. Listeria thrives in moist conditions.

Taken together, these challenges and deficiencies meant that opportunities to prevent Listeria contamination of products at the Maple Leaf plant were missed.

Food Safety Practices at Maple Leaf Foods

Something else that has since been confirmed by Maple Leaf Foods and the CFIA is that knowledge of the presence of Listeria, and their actions to control it, were not disclosed by Maple Leaf Foods to the CFIA inspection staff (not a regulatory requirement).

The CFIA inspectors did not ask specifically for this information and plant employees did not volunteer it. Maple Leaf Foods employees notified their superiors beyond Bartor Road into the Head Office, but this information did not reach the office of the Chief Executive Officer.

Equally noteworthy the company had invested in a specific Listeria environmental testing program (environmental results data software, compilation reports, remedial action plans), but this was not effectively implemented. Staff at the plant level did not look at the overall testing results to identify patterns that might indicate emerging problems. Further, we were told that corporate quality assurance officials did not conduct sporadic spot checks or undertake trend analyses.

Both Maple Leaf Foods and the CFIA have since acknowledged that, if the company had conducted meaningful trend analyses of its test results and shared these findings with the CFIA inspectors, the source of the contamination could have been identified sooner and the sale of unsafe foods may have been prevented.

There was another factor at play that fostered the conditions for Listeria to flourish. As referred to earlier, Maple Leaf Foods was producing larger packages of its ready-to-eat meat products for sale to institutions, including hospitals and long-term care facilities whose clientele are at higher risk of infection.

The company had created a recipe that uses less sodium, which was attractive to the institutional market as many of its clients benefited from reduced-sodium diets. However, reduced sodium levels in deli meats are known to increase the risk for bacteria growth, including Listeria.

Hospitals and long-term care homes first approached Maple Leaf Foods through one of its distributors about producing larger packages of this low-sodium product, to serve to their patients and residents. The company seized the opportunity to meet the needs of this new market (we were told from 20 cases a week to 2,000 to 3,000 cases a week). Since it considered that its practices were 'state-of-the-art', it did not adapt its food safety procedures to reflect the higher risks associated with lower sodium levels and larger packages.

It is generally accepted that the concept of zero risk is not achievable in the food processing business, but control measures need to be in place to eliminate risks to the greatest extent possible.

Although there were no regulatory requirements to put products on hold awaiting confirmation that they were Listeria monocytogenes free, the company still had an obligation to produce safe foods for the marketplace. An environmental 'hold and test' approach, as recommended by some experts, could have further reduced the risks, but was not in place at Bartor Road in the months leading to the event.

In the end, contaminated food left Bartor Road. And once contaminated packages left the plant, there was a possibility that vulnerable people could become ill.

Maple Leaf Foods has acknowledged a failure in the 'total food safety system' inside its plants. It has since recognized these problems and has increased its environmental testing program (hold and test). It has also introduced new measures to hold all products until test results indicate that they are Listeria free.

As well, the company is looking into other measures to reduce risk including additives, post-packaging high pressure treatment and other technologies that can control Listeria growth. And it is considering potential changes to its product packaging.

As Maple Leaf Foods has publicly acknowledged, for the hundreds of consumers who were affected by the contaminated products in 2008, this awareness comes late.

Key Findings:

• Two comprehensive reviews of the Maple Leaf Foods Bartor Road plant completed post-outbreak by Maple Leaf Foods International Expert Panel and the CFIA's In-depth Review Audit Team revealed numerous deficiencies that contributed to the outbreak.
• The food safety focus in Maple Leaf Foods Bartor Road plant, which has since changed, did not place a priority on controlling Listeria monocytogenes.
• Maple Leaf Foods' Bartor Road plant was aware that it had occurrences of Listeria in the plant in 2007 and 2008, and tried to correct the problem with sanitation procedures standard in the industry. As a result, the plant's management thought Listeria was under control.
• Employees in the plant were not required nor did they volunteer information concerning the repeated occurrences of Listeria in the plant to the CFIA Inspectors.
• Maple Leaf Foods staff notified their superiors of the repeated presence of Listeria beyond Bartor Road into the Head Office. However, this information did not reach the office of the Chief Executive Officer because it was thought that the plant's interventions had controlled the problem.
• Maple Leaf Foods did not conduct the trend analysis required under its Listeria control policy. Without this analysis, the recurring positive results were not known nor were the positive results verified to determine the presence/absence of Listeria monocytogenes.. This shortcoming, coupled with the significant demand for these deli meat products from institutions including hospitals and long-term care facilities, exposed a vulnerable population to unnecessary risk.
• In response to a market opportunity, Maple Leaf Foods produced and sold larger packages of its deli meat products, targeted specifically to institutions such as long-term care homes serving high-risk individuals, using a low-sodium recipe that increased the potential for Listeria to grow.
• Maple Leaf Foods has recognized the shortcomings of its past practices in controlling Listeria and has since taken measures to reduce the risk of reoccurrence.
• The corporate approach to food safety needs to evolve from one of compliance to one of individual commitment - from the Chief Executive Officer to the company janitor.
• The mandatory Hazard Analysis and Critical Control Point (HACCP) plan is a sound food safety approach for meat processing.

Recommendations to meat processors including, but not limited to, federally registered ones:

1. The CEO and senior management of all meat processors should accept oversight responsibility for ensuring that food safety is fully imbedded in every level of their business.
2. The CEO and senior management of all meat processors should ensure effective design and actively promote all aspects of food safety consistent with their Food Safety Plan.
3. Food safety plans should be regularly updated to ensure on-going attention to pathogen control.
4. All meat processors should ensure that new and existing equipment is and remains appropriate for the intended use.
5. Sanitation methods should be validated and implemented by meat processors in consultation with the equipment manufacturer, with a particular focus on the intended use and the products being processed on each piece of equipment.
6. To ensure active and transparent communications, all federally registered meat processors should disclose any threat to food safety occurring in their premises to the CFIA inspectors in a timely manner. Meat processors should not wait for requests for information from the CFIA inspectors and should, in the interests of food safety, ensure that inspectors have all information they require.

2. the federal meat inspection system did not identify these problems

How the system was designed

In addition to industry's food safety controls and in-house quality assurance processes, the Canadian Food Inspection Agency conducts inspections at registered food processing plants to ensure firms comply with federal laws and regulations. The inspections comprise an assessment of the company's compliance with its regulatory requirements which include its HACCP⁴ plan. The CFIA inspectors are required to conduct their inspection activities at registered federal meat plants each day. These duties include tasks to be completed daily, monthly, or annually, based on varying levels of risk. In a food processing ready-to-eat plant, such as Maple Leaf Foods on Bartor Road, tasks like verifying the plant's sanitation program are conducted monthly.

Coincidental to the events that led to the 2008 outbreak, a new federal meat inspection system (Compliance Verification System (CVS)) was introduced, in the spring of 2008, in the nearly 400 federally registered meat processing plants across the country. The CVS was implemented to streamline and integrate previous CFIA inspection approaches. It was first introduced as a pilot project in 2005, which involved approximately 120 plants, including Maple Leaf Foods on Bartor Road.

With the introduction of the CVS (which we heard is a more thorough approach), the CFIA inspectors are required to conduct a complete audit of a plant's key control systems once within a 24-month period, in addition to enhanced daily inspections.

Prior to this new meat inspection system, audits were scheduled to be conducted every three months, but they did not take place at Maple Leaf Foods Bartor Road plant at the prescribed frequency in 2005, 2006, or 2007. No audit took place in 2008, and they were only conducted three times over this three-year period.

We heard that the new inspection approach is considered a major improvement and sufficient to protect public safety. But we were told of gaps in its design and implementation as well as in the on-going management and delivery of the CVS. These deficiencies are noteworthy because inspection requirements can only be as strong as the regulatory policies and standards against which compliance is verified.

The gaps can be explained, in large measure, by the fact that the CVS was developed and implemented without establishing a detailed business case and in the absence of a rigorous senior management decision-making process. If senior management had been more engaged, the CFIA executives might have recognized that the new inspection system was being implemented without a detailed assessment of the resources available to take on these new tasks, relative to those needed to apply the new inspection approach. Senior executives might also have recognized that the Manual of Procedures for the meat inspection program needed updating.

Furthermore, the decision to proceed directly from the pilot to full implementation was made with limited evaluation of the pilot's strengths and weaknesses and without detailed costing and adequate determination of resources implications, including the need for supervision and training. We were told that an evaluation of the CVS pilot was prepared but was not discussed throughout the CFIA hierarchy.

We heard that, because these essential steps were not taken, gaps between the Meat Hygiene Manual of Procedures - the regulatory framework - and the CVS were never identified and, therefore, not resolved.

These disparities included the policy requirement to monitor the plant's pathogen practices, including Listeria controls. The CVS, as developed, did not include a clear task for inspectors to verify a company's Listeria environmental controls. We also learned that the CVS was designed to take into account the particularities of each plant's safety provisions contained in its HACCP plan, but this appears to have been lost in implementation.

As another example, the CVS required inspectors to take on different and expanded roles, especially in the area of inspecting the plants' food safety controls. This change required an evaluation of the tasks being assigned and the competencies of the people who would be carrying them out.

We learned that an assessment of competencies needed to deliver the CVS, as well as the resources required to fully implement it, was not undertaken by the CVS development team. Although training for the implementation of the CVS was developed, it was not fully delivered. There was no formal assessment of the need for change management support. It was also revealed that, since the CVS combined previously implemented food safety approaches, in-depth validation and evaluation steps were not deemed necessary.

We heard varying views on the level and adequacy of resourcing available to deliver this system.

A number of sources said that the lack of staff was a major constraint as was the pressure of time. The system's design did not take account of the number of inspectors or the time available to conduct the CVS tasks because of their other duties, nor did it take into account travel time from plant to plant. Inspectors assigned to Bartor Road were also responsible for several different plants in their district, necessitating travel between these companies daily. Without full consideration of all these factors, it was not possible to adequately assess the resource levels required to properly conduct the full range of activities assigned to inspectors..

We were also told that supervision, support, and oversight of inspectors were not adapted to the CVS. Further, it was reported that supervisors received minimal training to prepare them for their additional responsibilities.

In addition, we heard that a 'curiosity' factor was not always present in inspectors - understanding the difference between what is needed and what is important. Inspectors were not expressly encouraged to use their judgment, based on their education and experience, or to follow up if something struck them as unusual.

Some inspectors welcomed the CVS given that their workloads did not permit meat inspection tasks to be completed thoroughly. They indicated there was not enough time to take on extra food safety inspection duties outside of their required tasks. Others welcomed the very prescriptive nature of the CVS as they only had to follow the instructions they were given.

How it worked in practice

At the time that Listeria problems were starting to surface at the Bartor Road plant, inspectors were following their CVS work plans and doing the prescribed activities and their other duties (e.g. export certification) as well as travelling between plants. For example, the day shift inspector had seven different plants to cover (including cold storage facilities for export purposes). We heard that inspectors' workloads left them limited time to accomplish their tasks in depth. What's more the inspectors may have missed early warning signs due largely to the nature of their tasks, insufficient training and understanding of the new procedures and the supervision they received.

In addition, the inspectors were not scheduled to visit the plant between operating shifts when sanitation was taking place to observe whether the plant's sanitation team completely dismantled the equipment or to witness the company's quality assurance officers taking environmental samples. In the case of Bartor Road, these activities often occurred in the middle of the night, as the company was operating two shifts. This schedule reduced the potential that inspectors would pick up on possible problems.

More significantly, the Bartor Road plant's HACCP plan required environmental Listeria testing but the company was not obliged to report its test results to the CFIA. Equally notable, the CFIA inspectors had no obligation to request or examine the company's Listeria testing results under their CVS tasks. Had the CFIA inspectors reviewed these test results they could have identified the frequency of positive Listeria results and brought this concern to the attention of the plant management.

Other potential factors contributing to the outbreak were the general belief that both Maple Leaf Foods' food safety system and the CFIA's inspection system were reliable, and that the Bartor Road plant needed minimal oversight since it had historically not presented cause for concern.

The issues identified during the two post-outbreak reviews conducted by the Maple Leaf Foods panel of independent experts and the CFIA's In-depth Review Audit Team pointed to deficiencies in the inspection system.

Key Findings:

• The new federal inspection system (CVS) was put into effect in the spring of 2008 at the same time that Maple Leaf Foods' environmental testing was identifying Listeria at the Bartor Road plant.
• Insufficient consideration was given to the effect that the CVS would have on the ability of the inspectors to perform their tasks.
• Although the CVS is regarded as a sound system and has broad support, it needs critical improvements related to its design, planning and implementation.
• Training necessary to implement the new CVS system was developed but not fully delivered and lacked change management support.
• The lack of its adaptation to the specific risks of each plant weakened the implementation of the CVS.
• Under the CVS, the CFIA inspectors were not required to fully examine key food safety controls (e.g. sanitation program) or to verify how the company was reviewing its environmental testing results.
• In the lead-up to the outbreak, the number, capacity and training of inspectors assigned to Bartor Road appear to have been stressed due to their responsibilities at other plants, the complexity of Bartor Road including its size and hours of operation, and necessary adjustments required by the implementation of the CVS.
• Due to the lack of detailed information and differing views heard, we were unable to determine the current level of resources as well as the resources needed to conduct the CVS activities effectively. For the same reason, we were also unable to come to a conclusion concerning the adequacy of the program design implementation plan, training and supervision of inspectors, as well as oversight and performance monitoring.

Recommendations:

1. To accurately determine the demand on its inspection resources and the number of required inspectors, the Canadian Food Inspection Agency should retain third-party experts to conduct a resources audit. The experts should also recommend required changes and implementation strategies. The audit should include analysis as to how many plants an inspector should be responsible for and the appropriateness of rotation of inspectors.
2. The Canadian Food Inspection Agency should ensure that inspectors receive timely education and training specific to each function they perform. This education should be based on an assessment of the additional training required to address gaps in the knowledge and abilities of inspection staff. Inspectors should regularly receive a mandatory program on current trends in science and technology in the processing of food, including compliance and verification processes.
3. The Canadian Food Inspection Agency should equip its inspectors with modern technology (e.g. e-note pad) to increase their efficiency.
4. The Canadian Food Inspection Agency should amend its meat inspection system (CVS) to ensure:
   1. the appropriate human resources are available to respond to workload requirements;
   2. comprehensive training based on required competencies and skills;
   3. timely delivery of ongoing training; and
   4. supervision of inspection staff structured to encourage enterprise and accountability.

3. There were gaps in the federal rules governing meat production and inspection

Maple Leaf Foods has stated that it was meeting all federal legislative and regulatory obligations at the time of the outbreak. Even so, there were gaps in the regulatory framework that allowed this outbreak to happen.

As noted previously, the federal food safety framework is the responsibility of Health Canada and the Canadian Food Inspection Agency. The two organizations have interdependent roles: Health Canada is responsible for the Listeria monocytogenes Policy; which is complemented by the CFIA Meat Hygiene Manual of Procedures, which includes the CFIA testing program (i.e. equivalent to its internal instructions to inspectors).

Health Canada

Listeria monocytogenes Policy

When Health Canada's Listeria monocytogenes Policy was first published in 2004, it put Canada at the forefront of food safety policy. However, we learned that, even though it is only a few years old, it has not kept pace with rapid advances in science, knowledge and technologies.

The Policy sets the standards for the acceptable level of Listeria monocytogenes in ready-to-eat products and provides guidance to food processors and the CFIA inspectors about managing the risks of Listeria. If the bacterium is found on a company's equipment, the Policy indicates that the contaminated area is to be cleaned and to be retested. If these results come back negative, the company can continue to produce and ship its food products.

In the case of Maple Leaf Foods this Policy was followed and even exceeded, at the time Listeria was detected at the Bartor Road plant. However, the Policy measures were insufficient to address the underlying source of contamination (e.g. the slicing equipment where the bacterium was harboured).

The Policy offers no concrete advice on how industry should prevent Listeria contamination or how to meet the standards it sets, including environmental testing requirements. There is also no recognition that "harbourage sites," such as slicers, make it harder to identify and find Listeria.

The Policy references "trend analysis" but does not describe what is meant by the term nor does it offer advice on what outcomes or results are to be achieved by such analyses.

Key Finding:

• The current Health Canada Listeria monocytogenes Policy does not provide adequate direction on expected outcomes leaving room for interpretation by industry.
• The lack of integration between Health Canada and CFIA policies created gaps and overlap that led to confusion.

Recommendation:

1. Health Canada should complete the revision of its 2004 Listeria Policy, by no later than March 2010, and ensure that:
   1. the Policy outlines clearly and concisely the expected results for all identified food products where Listeria is a potential threat to human health, consistent with international standards;
   2. risk categories of ready-to-eat product are retained, although they should be more clearly defined;
   3. post-processing measures that control Listeria monocytogenes are considered when determining product risk categories; and,
   4. it focuses only on the safety of foods (i.e. should be a food safety standard) and not on providing risk management direction to the food industry or the Canadian Food Inspection Agency.

Food additives and technologies

As indicated in the previous chapter, Health Canada is also responsible for the approval of additives for use in foods to control or destroy pathogens. In addition, it approves many other substances and chemicals used during food processing and manufacture including food enzymes (e.g.: used in cheese production), colouring agents, gelling agents, and fining agents.

We learned that some food additives and technologies, which had been approved in other countries and could have reduced the risks associated with Listeria,had been waiting for Health Canada approval for several years. We were told that a backlog had built up and that each new product brought forward for approval was being considered on a 'first come, first served' basis. Even if these products had been approved, Maple Leaf Foods would not have been obligated to include them in their recipes or processes.

Key Findings:

• In approving food additives and technologies, Health Canada has not been taking into account food safety considerations when assigning priorities for approval of these substances and processes.

Recommendation:

1. Health Canada should review its approval processes and fast track, where appropriate, new food additives and technologies that have the potential to contribute to food safety giving particular attention to those that have been scientifically validated in other jurisdictions (provinces or countries).

Design of food processing equipment

Food processing plants use a vast array of tools and equipment on their production lines, including slicers and conveyors. This equipment, particularly in ready-to-eat plants, needs to be frequently cleaned and sanitized to produce safe foods. For this reason, its design must accommodate hygiene considerations.

Maple Leaf Foods' International Expert Panel concluded that the most likely origin (root source) of the contamination of deli meat products was deep inside a commercial meat slicer. The company has reported that to disassemble the meat slicing machines, thoroughly sanitize and then reassemble them, necessitated shutting down the plant for three days. Their conclusions are suggestive of design problems, which made regular cleaning of the commercial slicers both difficult and costly for the food processor.

The American Meat Institute has developed stringent specifications for the design of slicers and other equipment, which it identifies as "10 principles of sanitary design." The Institute confirms that equipment sanitary design and operation are critical to the control of Listeria contamination in ready-to-eat meat and poultry processing plants. The American Meat Institute believes that the sanitary design of equipment can be achieved "through a non-competitive and cooperative effort between customers and suppliers.. However, their specifications do not address peer-level review of the design, operation and recommended sanitation methods for food processing equipment.

Key Finding:

• Increased coordination and improved communication about food processing equipment is needed among the manufacturer, the food processor and the CFIA regarding design specifications and the validation of sanitation procedures.

Recommendations:

1. Manufacturers of food processing equipment should ensure that their specifications and instructions to users specifically emphasize the necessity to control the risk of pathogens, including Listeria monocytogenes.
2. In addition, manufacturers of food processing equipment should accept responsibility for the foreseeable impact of the design and operation of their equipment on food safety. The design and operation of, and recommended sanitation methods for all food processing equipment should:
   1. enable thorough cleaning and disinfection;
   2. allow for efficient and complete disassembly and reassembly when required;
   3. eliminate to the fullest extent possible all areas likely to harbour pathogens, including Listeria monocytogenes;
   4. wherever possible, use material that is scientifically validated to limit pathogen growth or survival; and
   5. be peer-reviewed (applicable only for the recommended sanitation methods).

The CFIA'S Meat Hygiene Manual Of Procedures

The federal Meat Inspection Act provides the authority for the Meat Hygiene Manual of Procedures (which is equivalent to a regulation). The manual requires food processors to control pathogens such as Listeria monocytogenes.  The manual, which is complemented by directives and guidelines, is the main document guiding the CFIA inspectors and operators of meat processing plants for the production of safe food.

The manual is not reviewed on a routine basis and at the time of the outbreak, was out-of date. Aside from being out of date, it is prescriptive in its approach. In an effort to be complete, the manual provides very generic information in most cases so food processors do not have a clear indication of what outcomes they should be working toward or how to control Listeria monocytogenes. In fact, although plants were expected to control pathogens, the manual offered no practical information on how to sample and test, what to test or which bacteria should be tested. The lack of precise detail in the instructions left too much room for interpretation, allowing almost any action to meet the written rule without achieving the outcome sought.

The Health Canada Listeria monocytogenes Policy is complemented by the CFIA testing program, which is equivalent to the internal instructions to inspectors. The testing program sets out the operational requirements for inspectors to monitor the safety of products identified by the standards in the Health Canada Policy.

In 2005, the CFIA updated its testing program, eliminating the obligation of inspectors to conduct environmental monitoring for Listeria on food contact surfaces in plants. This was done, at least in part, to better align and maintain equivalency with newly instituted requirements from the US Department of Agriculture. Canadian food processors need to match US requirements in order to continue exporting their products to this important market.

Key Findings:

• The latest CFIA Listeria directive does not distinguish between foods at much lower risk of harbouring Listeria (e.g. dried and frozen meats) and those that are much higher risk (e.g. deli meats, hot-dogs, soft cheeses)
• Out-of-date manuals and policies contributed to a weakened government oversight

Recommendations:

5. The Canadian Food Inspection Agency, in conjunction with and in conformity to the proposed revisions to Health Canada's Listeria Policy, should strengthen its February 2009 Listeria controls found in the Meat Hygiene Manual of Procedures to focus on control measures for Listeria in ready-to-eat meat products, in addition to the current environmental and product testing:
   1. to ensure that any required testing is a verification step to confirm the effectiveness of the company's Listeria control program and not a control program in itself;
   2. by differentiating the testing requirements to reflect the risk associated with each product (i.e. more testing for high-risk products and less for low-risk ones);
   3. by requiring the testing of non-food contact surfaces in the processing environment;
   4. by establishing 'hold and test' product control requirements following positive test results for Listeria on food contact surfaces as follows:
      1. several tests for Listeria on food contact surfaces should be conducted immediately on and around the area where positive results were found to determine:
         • if there is persistent contamination, or
         • if the previous positives have already been dealt with using standard sanitation procedures;
      2. if the follow-up tests are positive, then testing for Listeria monocytogenes must occur in products from the production line of concern⁵. During this testing phase, all products produced on that line and day (i.e. between two complete sanitation shifts) should be withheld from the marketplace until the results are known;
   5. by further defining expectations of trend analysis to identify weaknesses in the company's control programs (including its HACCP plan) by determining if a pattern of contamination is emerging.
6. The Canadian Food Inspection Agency should revise its monitoring programs (M-200 and M-205 plans), by tailoring the sampling frequencies to each plant based on risk factors including compliance history, product risks and target market (i.e. higher sampling frequency in some plants, lower in others.)
7. The Canadian Food Inspection Agency should review and update existing food safety programs, regulations and directives to best reflect current food safety practices.
8. The Canadian Food Inspection Agency should update its Food Safety Enhancement Program Manual to require food processors to include all standard operating procedures and good manufacturing practices in their food safety plan.
9. The Canadian Food Inspection Agency should ensure that the Meat Hygiene Manual of Procedures is updated whenever there is a significant change to the practices imposed on industry.
10. The Canadian Food Inspection Agency should formally communicate its expectation that registered meat processors will bring all information with potential consequences for food safety to the attention of their assigned inspector in a timely manner.

4. Once contaminated products entered the food supply, institutions served it to vulnerable populations

Another, quite reasonable assumption at the time of the outbreak was the general belief that 'ready-to-eat' meats, such as deli meats, are safe to eat without the need for additional preparation or precaution.

While true for the most part, in the case of vulnerable populations, contamination with Listeria monocytogenes can have serious consequences. Of the 57 eventual confirmed cases of listeriosis during this outbreak, 54 of the individuals who became ill were elderly people in hospitals and long-term care homes. The operators of these facilities served the ready-to-eat food products - working from the assumption, based on years of experience, that the products were nutritious, easy to chew and safe - without taking extra precautions or avoiding serving them to vulnerable populations.

Recommendation:

1. Organizations providing housing and/or food services to seniors and other vulnerable groups, including long-term care homes and hospitals, should be encouraged to adopt food safety practices aimed at vulnerable populations, including those most vulnerable to listeriosis (such as the practices set out in the British Columbia Guideline for Food Services or in guidelines issued by the other provinces and territories.)

5. As contaminated food was being consumed, the public health system slowly recognized the outbreak

In recent years, Canada, and indeed the world, has been confronted with wave after wave of health crises. From SARS and West Nile virus, to mad cow disease, the listeriosis outbreak and the H1N1 virus, we have been reminded of the threats such infections pose to our health. Canadian governments, industry, and citizens have strived to protect themselves from these threats.

The Public Health Agency of Canada was created in 2004 in response to SARS and the growing recognition that we need to better anticipate and plan for health emergencies and be better coordinated in our responses when they arise. The Agency has a mandate to prepare for and respond to public health emergencies, strengthen Canada's capacity to protect and improve the health of Canadians, prevent and control infectious and chronic diseases, and injuries, and promote health.⁶

Nevertheless, as a growing number of people started to get seriously ill in the summer of 2008, weaknesses in the system became apparent.

As it became increasingly clear that this was likely a foodborne emergency⁷ and people were treated, the public health sector gradually responded but there were delays in mobilizing a full response. With the benefit of hindsight, the reasons for the gradual response are more evident.

First, listeriosis is both less common than other foodborne illnesses and more difficult to diagnose, so it was not immediately obvious that an outbreak was emerging. When isolated cases of listeriosis are detected, they are generally dealt with at the local level. This is normal, and a small number of cases does not immediately trigger suspicion or provoke an emergency response. There are routinely five to six such cases reported each month in Ontario. It was only when clusters of listeriosis cases became apparent in different communities across Ontario that there was increased action at the provincial and, eventually, the national level.

The next challenge faced by the public health sector was determining which food was causing the illness and establishing the source of this food. Most foodborne illnesses are caused by contamination of food while it is being handled or prepared.

With this understanding, Toronto Public Health inspectors used a standard investigative approach in investigating the initial listeriosis cases. This included determining the likelihood of food handling contamination at the institution and through testing of food, a determination of how the pathogen found its way into the kitchen. In this instance, with two illnesses from the same Toronto area long-term care home, and with no other illnesses yet linked, the public health inspectors' focus was primarily on the possibility of cross-contamination resulting from the way food was handled in the kitchen, and secondarily on where the food might have been manufactured.

A further factor is that, traditionally, foodborne illness outbreaks were traced to locally produced and distributed food products. This is less and less the case in today's world of globalization and large scale food production. So in the first few days, the public health inspectors did not immediately suspect a nationally distributed food product.

How the public health surveillance system worked in practice

There is a patchwork of disease reporting and recording procedures used across the country. The approach varies from one jurisdiction to the next. For example, in British Columbia physicians were not required to report listeriosis cases. These differences do not matter when an illness is confined to one province but, as soon as it jumps borders, these variations matter.

An additional factor was that Ontario had recently changed its surveillance system. In the aftermath of SARS, Ontario had instituted new disease detection and prevention measures in its public health system. The improvements included iPHIS (integrated Public Health Information System), a web-based system used by all public health units to report infectious, communicable and foodborne diseases, and EARS (Early Aberration Reporting System), which detects increases in cases to identify an outbreak when the number exceeds the norm.

Ontario's iPHIS and EARS

• In 2005, Ontario developed and put into place a web-based system: integrated Public Health Information System (iPHIS)
• All 36 public health units in Ontario are legally obligated to enter case information on all notifiable diseases (including listeriosis) into iPHIS
• The Public Health Division (of Ontario's Ministry of Health and Long-Term Care) monitors and analyzes the iPHIS data daily - supported by a program called Early Aberration Reporting System (EARS)
• EARS detects statistical increases in the number of cases above the norm and therefore can helps Public Health Division officials detect an outbreak

We were told that the new system was better than what existed before but that it was not as effective as public health officials believed at the time. iPHIS and EARS were not yet fully developed nor completely implemented, particularly for monitoring foodborne illness. Public health units were required to upload notifiable disease data into iPHIS but we heard that local resources were not readily available to input all the information on a timely basis.

Delays in entering local data, coupled with incomplete records, held up the epidemiological investigation at the provincial level. These investigationsare vital to assess the risks to the general population or to identify specific groups at increased risk.

Also problematic, the early warning system was not as helpful as intended because local public health units only had access to the data of their district but could not access the data of the other 35 Ontario public health units and therefore could not see the spread of disease across the province. At the time of the outbreak, the data was only available to some sections within the Ontario Ministry, and the information received was not complete.

While the reasons are numerous and, in retrospect, understandable, the fact remains that the data on the listeriosis cases that began to appear in July of 2008 was not entered immediately into iPHIS by many local public health units. As a result, the Ontario Ministry did not have all the information it needed to assess the 'bigger picture'. Without all the necessary facts at hand, officials did not fully understand the level of contamination in the food supply and thus were unable to issue early health advisories to institutions caring for vulnerable populations or the general public until the outbreak was well advanced.

Key Findings:

• The pattern of isolated cases occurring in different public health units across Ontario, over a number of weeks, meant that the small increase in cases was hard to identify
• Early in the outbreak, there were delays in some local public health units to enter case information into Ontario's surveillance system; this improved over the course of the outbreak when the Ontario Chief Medical Officer of Health requested that they enter listeriosis cases into the system on an urgent basis
• In the 2008 outbreak, the Ontario surveillance systems helped detect the Ontario-wide outbreak; without these systems, the outbreak would have been detected later - possibly after more vulnerable people became ill
• The approach to gathering food samples by local public health staff at the long-term care home was geared towards identifying a local source for the outbreak (e.g. cross contamination in the kitchen). this delayed identification of the commercial food source

Recommendation:

1. The federal, provincial and territorial governments should continue to use and support surveillance and monitoring systems, such as the Canadian Integrated Outbreak Surveillance Centre (CIOSC), and consider the development of next generation systems (e.g. Panorama).

Next chapter

"The chain of events that led to the initial identification of the outbreak and the eventual recall of contaminated meats produced by Maple Leaf Foods is not easily or succinctly explained..."

¹ The "Hazard Analysis and Critical Control Point" (HACCP) places the responsibility on the food producer to ensure that the product is safe to be consumed. Proposed by the Codex Alimentarius Commission for the food industry in general, and meat, poultry, and seafood industry in particular, it has been adopted by some 150 countries.

² Environmental testing: a group of tests used to determine if food contact and non-contact surfaces, such as a slicer, equipment, refrigeration units or ceilings (over production lines) are Listeria free. Testing is conducted using a sterile cotton swab or a sponge wiped on a selected portion of each pre-determined surface. The swab/sponge is also known as a sample, and is then tested to see if any bacteria can be found.

³ "Casing" type products are various food products which are cooked in an envelop (casing) before being sliced (such as mock chicken, bologna, pepperoni, salami, and summer sausage)

⁴ The "Hazard Analysis and Critical Control Point" (HACCP) places the responsibility on the food producer to ensure that the product is safe to be consumed. Proposed by the Codex Alimentarius Commission for the food industry in general, and meat, poultry, and seafood industry in particular, it has been adopted by some 150 countries.

⁵ The testing requirements (e.g. number of tests) should be based on an authoritative source such as the International Commission on Microbiological Specifications for Food and should be consistent with the Health Canada's Listeria Policy.

⁶ Public Health Agency of Canada, About the Agency. Who We Are; What we Do, online

⁷ A foodborne emergency occurs when people are becoming ill from a common contaminated food source.